The Effect of Brief Interventıon on Behavıoral Change, Anthropometrıc and Metabolıc Varıables In Overweıght Women wıth Low Health Lıteracy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Evaluation of weight change
研究概览
简要总结
This study will evaluate the effect of a brief intervention on anthropometric and metabolic changes in overweight women with low health literacy. The total number of samples was determined as 88. It was decided to recruit a total of 124 people, 62 people in each group, with a 40% loss in the groups. Brief intervention interviews will be conducted with the intervention group. Brief intervention interviews will take an average of 20-30 minutes and four times. The control group will not be intervened except for the first and last evaluations.
详细描述
This study will evaluate the effect of a brief intervention on anthropometric and metabolic changes in overweight women with low health literacy. The total number of samples was determined as 88, 44 in each of the intervention and control groups. It was decided to recruit a total of 124 people, 62 people in each group, with a 40% loss in the groups. Randomization will be performed after obtaining consent from the participants who meet the eligibility and exclusion criteria. The sampled individuals will be assigned to the Intervention and Control groups according to the block randomization method. Brief intervention interviews will be conducted with the intervention group. It was determined as the first evaluation and the follow-ups on the 1st day, 15th day, 1st month, 3rd month, and the last evaluation (6th month). Brief interventions, 5A for those who are ready to change their behavior (Ask, Advise, Assess, Assist, Arrange); those who are not ready to change their behavior 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) model will be used. At the end of brief interventions applied to overweight women with low health literacy for 20-30 minutes, a total of four times; weight change, waist circumference change, blood pressure change, blood glucose change, blood lipid change, diet, and exercise behaviors will be evaluated. The control group will not be intervened except for the first and last evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
For each group, 21 blocks were created by generating random numbers in Excel by a person other than the researcher and assigned to groups A and B. The assignment of the intervention and control groups was made by drawing lots. Index cards prepared for two primary healthcare organizations by block randomization by the researcher who did not participate in the clinical part of the study will be placed in closed opaque envelopes and their sequence numbers will be written on the envelopes. The research data will be entered into the computer database by the researcher as coded as A and B. Statistical analyses will be performed by the researcher who did not participate in the data collection phase according to this code. The research report will also be written in coded form. Research participants and statistical evaluators were planned to be blind to group assignment, single-blind, and statistician blind.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having heart disease, stroke, and chronic kidney failure diagnosed by a physician,
- •Having diabetes that requires the use of insulin,
- •Having hypothyroidism that prevents weight loss,
- •Participating in a weight management program in the last 3 months,
- •Being diagnosed with a disease that causes deterioration in cognitive processes such as Alzheimer's and dementia,
- •Having a diagnosed physical or neurological problem that prevents him from doing physical activity,
- •People who plan to become pregnant or become pregnant during the trial period (8 months after enrollment in the trial)
排除标准
- •Between 12.09.2023 and 24.06.2024 two Primary healthcare organization applied,
- •Volunteered to participate in the research,
- •Women between the ages of 30-65,
- •The level of health literacy is limited-restricted,
- •25≥ BMI < 30,
- •Those who can read and understand Turkish will be included in the study.
结局指标
主要结局
Evaluation of weight change
时间窗: Change from before implementation three and six months of practice.
The weight will be evaluated by measuring the weight.
次要结局
- Evaluation of blood lipid changes (Total cholesterol, HDL, LDL cholesterol, and triglyceride level)(Change from before implementation and six months of practice.)
- The eating habits will be evaluated using the Nutrition Processes of Change Scale.(Change from before implementation and six months of practice.)
- Waist circumference measurement and evaluation(Change from before implementation, three and six months of practice.)
- Evaluation of glycosylated hemoglobin A1c (HbA1c) level(Change from before implementation and six months of practice.)
- The exercise habits will be evaluated using the Exercise Behavior Change Model Scales.(Change from before implementation and six months of practice.)
- The Mediterranean diet will be evaluated using the Mediterranean Diet Adherence Screener (MEDAS).(Change from before implementation and six months of practice.)
- Measurement and evaluation of blood pressure (BP)(Change from before implementation, three and six months of practice.)
- Evaluation of fasting plasma glucose level(Change from before implementation and six months of practice.)
- Body mass index (BMI) evaluation(Change from before implementation, three and six months of practice.)
研究者
Yasemin Guven
Research Assistant
Mersin University